Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of the Pharyngeal Cavity Versus Benzidamine Hydrochloride

Phase 4

Completed

• Conditions: Pharyngitis
• Interventions: Drug: Benzidamine hydrochloride; Drug: Ketoprofen lysine salt

• Registration Number: NCT02178293
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

A study to in order to verify any differences between the 2 treatment groups in terms of duration of analgesic effects after the first drug intake and time to remission of symptoms and signs of pharyngitis

Detailed Description

Not available

Study Timeline

• Study Start: 1998-09
• Primary Completion: 1999-05
• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-06-30
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-04
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• Male and female outpatients, aged 18 to 70 years, suffering from acute pharyngitis, pharyngolaryngitis
• Moderately or severely intense pain in the pharyngeal region (score ≥ 70 mm) from the "visual analogue scale" (VAS)
• At least 1 of the 2 inflammation signs (edema and hyperemia) to be moderately or severely intense (score ≥ 2) from the scoring scale from 0 to 3
• Release of written informed consent by the patient

Exclusion Criteria

• Patients suffering from a microbial infection requiring specific antimicrobial treatment
• Patients who have taken the trial drugs during the week before enrolment
• Patients who have taken corticosteroids or antibiotics during the week before enrolment
• Ascertained or suspected hypersensitivity to trial drugs or to chemically correlated drugs or to other non-steroidal anti-inflammatory drugs or to mouthwashes in general
• Patients who are unable to properly fill in the diary every day as provided for by the protocol
• Ascertained or presumed pregnant or lactating women
• Inclusion in any other clinical trial during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Benzidamine hydrochloride	Benzidamine hydrochloride	-
Ketoprofen lysine salt	Ketoprofen lysine salt	-

Primary Outcome Measures

Name	Time	Method
Duration of analgesic effects in hours	Up to 6 hours

Secondary Outcome Measures

Name	Time	Method
Average severity of edema and hyperemia, assessed by investigator on a 4-point-scale	Up to day 8
Average number of days required to obtain remission of pain	Up to day 8	day on which 2 consecutive pain measurements are both below 10 mm of the visual analog scale (VAS)